Trial Outcomes & Findings for Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects (NCT NCT01924182)

Results Overview

Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

3 Month

Results posted on

2018-03-29

Participant Flow

Seven participants were enrolled (consented).

Of the 7 participants that were enrolled, 3 met the randomization eligibility and were randomized to the IT Group. Of the 3 participants randomized, 2 were implanted.

Participant milestones

Participant milestones
Measure	IT Group (SynchroMed/Intrathecal Morphine Sulfate) Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control. SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.	Conventional Medical Management Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
Overall Study STARTED	3	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IT Group (SynchroMed/Intrathecal Morphine Sulfate) Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control. SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.	Conventional Medical Management Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IT Group (SynchroMed/Intrathecal Morphine Sulfate) n=3 Participants Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control. SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.	Conventional Medical Management Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.	Total n=3 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 11.8 • n=93 Participants	—	56.2 years STANDARD_DEVIATION 11.8 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	—	2 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Baseline patient-reported pain diary score	7.0 units on a scale STANDARD_DEVIATION 1.4 • n=93 Participants	—	7.0 units on a scale STANDARD_DEVIATION 1.4 • n=27 Participants
Baseline 23-item toxicity score	8.7 units on a scale STANDARD_DEVIATION 3.8 • n=93 Participants	—	8.7 units on a scale STANDARD_DEVIATION 3.8 • n=27 Participants

PRIMARY outcome

Timeframe: 3 Month

Population: 2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the primary outcome assessment, no statistical analysis will be presented.

Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).

Outcome measures

Outcome measures
Measure	IT Group (SynchroMed/Intrathecal Morphine Sulfate) n=1 Participants Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control. SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.	Conventional Medical Management Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
Clinical Success	1 participants	—

SECONDARY outcome

Timeframe: 3 Month

Population: 2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the secondary outcome assessment, no statistical analysis will be presented.

Compare changes from Baseline to Month 3 between the IT group and CMM group in Numeric Pain Rating Scale (NPRS). The scale measures pain intensity. Using NPRS, a pain score ranging from 0 (no pain) to 10 (pain as bad as you can imagine) is recorded on a subject diary twice daily for 5 days before a study visit. The score for each visit is calculated as the mean pain of the 5 diary days morning and evening scores. For each subject, the change in pain will be calculated as the mean pain score at Month 3 minus the mean pain score at Baseline. A negative change value represents a lowering of the pain score (an improvement, or reduction in pain).

Outcome measures

Outcome measures
Measure	IT Group (SynchroMed/Intrathecal Morphine Sulfate) n=1 Participants Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control. SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.	Conventional Medical Management Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
Pain Assessment	-3.3 units on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: 3 Month

Population: 2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the secondary outcome assessment, no statistical analysis will be presented.

Summarize the changes from Baseline to Month 3 between the IT group and CMM group in Common Terminology Criteria for Adverse Events (CTCAE) toxicity score. (from the National Cancer Institute) A subset of 23 specific items of the CTCAE v4.03 were evaluated. The subset was chosen as these criteria were most related to opioid side effects that are of interest in this study. The investigator scored the assessment at each visit. The total score for a visit is based on the sum of 23 individual CTCAE's. The individual scales have a range of 0 to 2, 0 to 3, or 0 to 5 and the total score ranges from 0 (best case) to 90 (worst case). For each subject, the change in toxicity will be calculated as the total toxicity score at Month 3 minus the total toxicity score at Baseline. A negative change value represents a lowering of the subjects toxicity score (an improvement, or reduction in toxicity).

Outcome measures

Outcome measures
Measure	IT Group (SynchroMed/Intrathecal Morphine Sulfate) n=1 Participants Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control. SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.	Conventional Medical Management Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
Opioid-Related Side Effects	-6 units on a scale Standard Deviation 0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Month

Population: 2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the outcome assessment, no statistical analysis will be presented.

Compare changes from Baseline to Month 3 between the IT group and CMM group for Apnea-Hypopnea Index (AHI). The AHI was collected via overnight sleep lab polysomnography. The AHI is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI values for adults are categorized as Normal: AHI\<5, Mild sleep apnea: 5≤AHI\<15, Moderate sleep apnea: 15≤AHI\<30, Severe sleep apnea: AHI≥30. For each subject, the change in AHI will be calculated as the AHI at Month 3 minus the AHI at Baseline. A negative change value represents a lowering of the subjects AHI (an improvement, or reduction in sleep apnea).

Outcome measures

Outcome measures
Measure	IT Group (SynchroMed/Intrathecal Morphine Sulfate) n=1 Participants Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control. SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.	Conventional Medical Management Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
Sleep Assessment	-10.4 units on a scale Standard Deviation 0	—

Adverse Events

IT Group (SynchroMed/Intrathecal Morphine Sulfate)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Conventional Medical Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IT Group (SynchroMed/Intrathecal Morphine Sulfate) n=3 participants at risk Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control. SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.	Conventional Medical Management Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
Infections and infestations Respiratory tract infection bacterial	33.3% 1/3 • throughout the study duration, from enrollment to 3 months follow-up after implant, an average of 4 months	— 0/0 • throughout the study duration, from enrollment to 3 months follow-up after implant, an average of 4 months

Additional Information

Mary Markert Sr Prin Clinical Research Specialist

Medtronic Neuromodulation

Phone: 763-526-8162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restrictions on the PI allow for the sponsor to review results communications prior to public release and to embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to sponsor for review. The sponsor is also allowed to require changes for technical correctness and to protect confidential information, copyrightable or patentable material; and when reasonably requested, extend the embargo up to an additional 90 days.
Publication restrictions are in place

Restriction type: OTHER